Cangrelor · Regulatory approval

FDA approval: Cangrelor

U.S. Food and Drug Administration · June 4, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved cangrelor powder for intravenous injection (50 mg per vial) on 4 June 2026 under ANDA 213703. This record documents the regulatory action alone and contains no clinical trial results, efficacy data, or safety evidence.

What was studied

Regulatory approval.

Key findings

FDA approval granted for CANGRELOR POWDER, INTRAVENOUS, 50 MG/VIAL on 2026-06-04

Safety

This record does not contain clinical trial results, efficacy data, safety summaries, or comparative evidence. No information on indication, dosing schedule, patient population, or adverse events is provided in this regulatory record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of cangrelor powder for intravenous use; this is a regulatory action record that does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-04

Dose formulation50 MG/VIAL

RouteINTRAVENOUS

Caveats

This record does not contain clinical trial results, efficacy data, safety summaries, or comparative evidence.
No information on indication, dosing schedule, patient population, or adverse events is provided in this regulatory record.
Approval does not imply efficacy; the underlying NDA/ANDA review documents would contain trial data.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory record, not a clinical study.

Directness

insufficient

No clinical outcomes or comparators reported in this record.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Regulatory record does not report trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or population data reported in this record.

Source abstract

Drugs@FDA record for application ANDA213703. This is a regulatory action record, not a clinical study. Brand name: CANGRELOR. Active ingredient: CANGRELOR. Sponsor: MSN. Submission type: ORIG (original application). Approval status date: 2026-06-04. Products: CANGRELOR, POWDER, INTRAVENOUS, CANGRELOR 50MG/VIAL.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

CangrelorMSN